Low Energy Direct Current Thermal Ablation System

What Is This Device?

Ablation of soft tissue

What Is FDA Product Code OAB?

Low Energy Direct Current Thermal Ablation System is FDA product code OAB, Class 2, 21 CFR 878.4400.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 3 clearances under this code; the FDA took a median of 253 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 4 recalls under this product code since 2011. None was by a company in China. The root causes the FDA records most often are Labeling False and Misleading (1), Component design/selection (1) and Software Manufacturing/Software Deployment (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.